NCT00950664

A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia

A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® in Comparison With Botox®, Assuming a Bioequivalence Ratio of 2.5:1 Units, in the Cervical Dystonia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia. 2. double blind, randomised, multi center, crossover study

Detailed description

1. Prospective, randomized, head-to-head, double-blind, cross-over study. 2. Total patients: A group 51, B group 51 3. Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, then the patients get the other treatment (i.e, Patients who have got Dysport will be then administered with Botox) 4. Compare the TSUI change score from baseline to 4 weeks after injection.

Conditions

• Cervical Dystonia

Interventions

Type	Name	Description
DRUG	Dysport® (abobotulinumtoxinA)	Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
DRUG	Botox® (onabotulinumtoxinA)	Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-01-01
• Completion: 2011-07-01
• First posted: 2009-08-03
• Last updated: 2017-07-05
• Results posted: 2013-10-11

Locations

7 sites across 1 country: South Korea